BVI Medical, a global leader in ophthalmic device innovation, announced that the U.S. Food and Drug Administration (FDA) has approved its FINEVISION HP trifocal intraocular lens (IOL). This milestone underscores BVI’s leadership in premium IOLs and expands access to advanced vision correction solutions for patients in the United States.
The FINEVISION HP is the world’s first trifocal IOL, recognized globally for its patented diffractive optic design, which provides balanced vision at far, intermediate, and near distances. Developed through the pioneering efforts of Christophe Pagnoulle, BVI R&D Director, and ophthalmologist Dr. Damien Gatinel, the lens has over 15 years of clinical success and millions of implantations worldwide, setting a benchmark for premium cataract surgery.
“FINEVISION HP redefined premium cataract surgery and continues to set the gold standard in premium IOL innovation,” said Shervin Korangy, President and CEO of BVI. “This FDA approval marks a pivotal step in expanding our IOL portfolio in the United States, supporting our mission to deliver best-in-class visual outcomes for patients globally.”
The third-generation FINEVISION HP incorporates BVI’s proprietary POD platform and CoPODize™ technology, which harmonizes light distribution and minimizes visual disturbances. Its double C-loop, four-point haptic design ensures long-term stability and precise centration in the capsular bag, enhancing patient outcomes.
“The development of FINEVISION HP was a pivotal moment for ophthalmology, reshaping expectations for vision correction after cataract surgery,” said Dr. Damien Gatinel. “FDA approval in the U.S. means even more patients will benefit from this breakthrough technology.”
Clinical and Market Significance
Category Creation: FINEVISION HP introduced the world’s first trifocal IOL, establishing a new standard for cataract surgery.
Proven Reliability: With over a decade of clinical data and millions of successful implantations, FINEVISION HP remains the most trusted trifocal lens worldwide.
Innovative Design: The POD platform and CoPODize™ technology optimize light distribution and reduce visual disturbances, while the double C-loop haptic system ensures stability and precise positioning in the eye.
The U.S. clinical study further validated the lens’s performance, demonstrating its potential to transform patient care in the U.S.
“The FINEVISION HP trifocal IOL reflects innovation in optic design, and I’m pleased to have been part of the U.S. study evaluating its performance. This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients,” said Dr. Vance Thompson, study investigator.
With early indications suggesting demand may exceed supply, BVI is investing in capacity expansion and plans to methodically roll out availability over the coming year. This FDA approval positions BVI to strengthen its footprint in the U.S. premium IOL market and continue its global legacy of innovation in vision correction.